Paul M. Coates, Ph.D.

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1 Dietary Supplements in the United States: Claims and Evidence The National Institute of Health and Nutrition December 2008 Paul M. Coates, Ph.D. Office of Dietary Supplements National Institutes of Health Department of Health and Human Services

2 Overview Evening Primrose Oenothera biennis A Brief History of Dietary Supplements The US Environment for Claims The Office of Dietary Supplements (ODS) Issues in Dietary Supplement Research

3 DSHEA (Dietary Supplement Health and Education Act ) Amended the Food, Drug & Cosmetic Act Defined dietary supplements Established regulatory framework Food and Drug Administration (FDA) As foods, not as drugs Established rules for what a label should contain Gave FDA authority to write GMPs Called for creation of the Office of Dietary Supplements at the NIH

4 Dietary Supplement: DSHEA Definition Product intended to supplement the diet Contains one or more of the following: Vitamin Mineral Amino acid Other dietary substance Herb or other botanical (not tobacco) Not a conventional food

5 Regulation of Dietary Supplements in the United States Rules for foods, not drugs, apply to dietary supplements An ingredient is presumed safe based on its history of use in humans

6 U.S. Supplement Sales ($Billions) 1994: ~4,000 supplement products 2008: ~75,000? Source: Nutrition Business Journal

7 Dietary Supplement Sales in 2006: $22.5 Billion Other Supplements ($8.5) Multivitamins/Minerals ($4.3) Vitamins ($3.2) Botanicals ($4.6) Minerals ($1.9) Source: NBJ, derived from a variety of sources

8 Top 10 Dietary Supplements for 2006 Multivitamins/minerals Calcium B vitamins Vitamin C Glucosamine/Chondroitin Fish oils Vitamin E Coenzyme Q10 Vitamin A Probiotics Nutrition Business Journal

9 Botanicals Phytomedicines Foods of plant origin

10 Types of Claims Health claims Nutrient content claims Qualified health claims Structure/function claims

11 Basis for Claims Congress 1990: Nutrition Labeling and Education Act (NLEA) 1994: Dietary Supplement Health and Education Act (DSHEA) 1997: FDA Modernization Act (FDAMA) Case law (judiciary) Rules and regulations by FDA & FTC

12 Justifications for Allowing Claims Encourage consumption of good foods Allow for food comparisons Provide level playing field Incentive to manufacture better food products

13 NLEA: Health Claim Substance Food: apple Component: folic acid Disease Cancer Health-related condition High cholesterol

14 Evaluating the Science Standard of evidence: significant scientific agreement (SSA) Quantity of studies Methodological quality Study outcomes Consistency of relationship Relevance to US population

15 FDA Approved Health Claims Calcium & osteoporosis* Sodium & hypertension* Saturated fat & cholesterol & CHD* Lipids (fats) & cancer* Fruits, veggies & fiber-containing grains & CHD* Folic acid & NTDs* Non-cariogenic carb. sweeteners & dental caries Soluble fiber & CHD Soy protein & CHD Plant stanol/sterols & CHD Fruits & veggies & cancer* Fiber-containing grains, fruits & veggies & cancer*

16 Health Claim: Calcium & Osteoporosis FOOD OR SUPPLEMENT High in calcium Bioavailable Pills must disintegrate & dissolve Amount of calcium > phosphorus MODEL CLAIM Regular exercise and a healthy diet with enough calcium helps teens and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life. CLAIM REQUIREMENTS Disease depends on many risk factors Primary target population Additional factors to reduce risk Mechanism of link: optimize peak bone mass If >400mg calcium, note that intakes >2,000mg provided no added bone benefit

17 Core claims: NLEA: Nutrient Content Claims free, low, lean, extra lean, high, good source, reduced, less, light, fewer, more Nutrients Good : 10-19% DV Rich, Excellent, High : >20% DV

18 Qualifying Health Claims SSA disallows free speech? 1999 Pearson v. Shalala Permit potentially misleading claims using qualifying language Disclosure over suppression

19 Consumer Health Information for Better Nutrition Initiative Scientific Ranking FDA Category Appropriate Qualifying Language First level A None; SSA; a true health claim Second level B...although there is scientific evidence supporting the claim, the evidence is not conclusive Third level C Some scientific evidence suggests [a relationship]; however, FDA has determined that this evidence is limited and not conclusive Fourth level D Very limited and preliminary scientific research suggests [a relationship]; however, FDA concludes that there is little scientific evidence supporting this claim

20 Qualified Health Claims: FDA Enforcement Discretion 0.8 mg folic acid & neural tube defects & recurrent colon/rectal polyps B vitamins & vascular disease Selenium & cancer Antioxidant vitamins & cancer Phosphatidylserine & cognitive dys- function & dementia Nuts & heart disease Walnuts & heart disease Omega-3 fatty acids & CHD Calcium & hypertension, pregnancyinduced HBP & preeclampsia Tomatoes and/or tomato sauce & prostate, ovarian, gastric, and pancreatic cancers Unsaturated fatty acids from canola oil and reduced risk of CHD Corn oil and corn-oil containing products and a reduced risk of heart disease Monounsaturated fatty acids from olive oil & CHD Green tea & cancer Chromium picolinate & diabetes Calcium & colon/rectal cancer. Calcium

21 Qualified Health Claim: Chromium Picolinate & Diabetes One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.

22 DSHEA Statements of Nutritional Support for Suppplements Structure/function claims Describes role of ingredient or its mechanism intended to affect the structure or function in humans Must not claim to diagnose, mitigate, treat, cure, or prevent disease Manufacturer has substantiation that statement is truthful and not misleading Does not require prior FDA approval Must include disclaimer on label

24 Structure/Function vs. Disease Claims Structure/Function Claims Disease Claims Helps maintain normal cholesterol levels Lowers cholesterol Maintains healthy lung function Maintains healthy lung function in smokers Provides relief of occasional constipation Provides relief of chronic constipation Suppresses appetite to aid weight loss Suppresses appetite to treat obesity Supports the immune system Supports body s antiviral capabilities Relief of occasional heartburn or acid indigestion Relief of persistent heartburn or acid indigestion For relief of occasional sleeplessness Helps reduce difficulty in falling asleep Arouses sexual desire Helps restore sexual vigor, potency, performance

26 Health-Related Claims: Clear or Confusing? Always a debate Health professionals vs. industry Remarkably little study 2005 survey by Intl. Food Information Council (IFIC) 2007 FDA survey Different types of claims Different levels of scientific rigor

28 The National Institutes of Health

29 NIH is the Nation s Medical Research Agency 27 Institutes and Centers Total NIH Budget for 2008: $28 billion Grants, Contracts, Cooperative Agreements Department of Health & Human Services Along with FDA, CDC and other agencies

30 ODS Mission Is to Strengthen Knowledge and Understanding of Dietary Supplements Evaluate scientific information Stimulate and support research Disseminate research results Educate the public to foster an enhanced quality of life and health Echinacea Echinacea purpurea

31 ODS Evidence-Based Review Program Systematic review of the literature, with meta-analysis as appropriate, on DS efficacy and safety Major reason for conducting these reviews is to assist NIH in the development of research agendas Examples: omega-3 fatty acids, soy, vitamin D, chromium

32 Evidence Pre-Clinical Ecologic Observational Cohort Intervention RCT

33 Dietary Supplement Research: Product Concerns Identification Characterization Reproducibility Black Cohosh Cimicifuga racemosa L.

34 ODS Analytical Methods and Reference Materials Program Methods/reference materials for: Research needs Quality assurance/quality control Raw material qualification Identity, purity, strength Finished product release Purity, strength Regulatory purposes Identity, purity, declared strength

35 Dietary Supplement Research: Protocol Concerns Population(s) Generalizability Endpoints Dose Earlier Phase Studies Red Clover Trifolium pratense

36 Current Issues Trials of single ingredients or combinations Selenium/vitamin E (SELECT) Ginkgo biloba Antioxidant vitamins Dietary Reference Intakes Vitamin D and Calcium

37 Website:

FDA HEALTH CLAIM AND QUALIFIED HEALTH CLAIM GUIDELINES

FDA HEALTH CLAIM AND QUALIFIED HEALTH CLAIM GUIDELINES AG BM 302 Food Products Marketing Prof. Colby Penn State University From Guidance for Industry: A Food Labeling Guide (Appendix C: Health Claims and